Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.

FDA recall notice · announced September 18, 2013 · Creative Compounds

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070.

Reason for recall

Glutathione 100 mg/mL injectable human drug is recalled due to Out Of Specification results or potential bacterial contamination and it was reported as passing by a contract laboratory.

Notes

Distribution: Oregon and Washington
Lot/code information: Lot #: 20130715@12, Exp10/13/2013
Quantity: 16 vials
Status: Terminated
Products in this recall event:
- Glutathione 100 mg/mL Injectable, 100mL Vial, Use as Directed, RX, Creative Compounds, Wilsonville, OR 97070. (D-1019-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.